Country Approval Specialist – Regulatory Submissions

About the role

The Country Approval Specialist is responsible for preparing, reviewing and coordinating local regulatory submissions in line with the global submission strategy. Working closely with internal teams and local authorities, the role ensures timely and compliant delivery of country‑specific dossiers such as HSA, EC, gene‑therapy approvals, viral safety dossiers and import licences.

Key responsibilities

• Prepare, review and submit local regulatory applications (HSA, EC and other national filings) following global strategy.
• Provide regulatory strategy advice to internal stakeholders and develop country‑specific submission plans.
• Act as primary liaison with investigators and local regulatory authorities, handling complex issues in collaboration with the local regulatory manager.
• Coordinate with Clinical Operations, Legal, Project Management and Finance to align site start‑up activities with submission timelines.
• Lead contract and budget negotiations with investigative sites, ensuring compliance with sponsor requirements and local regulations.
• Identify, escalate and resolve regulatory, contract and budget risks that could impact study activation.
• Develop country‑specific Patient Information Sheets and Informed Consent Forms.

Required profile

• Strong understanding of local regulatory frameworks (e.g., HSA, EC) and global submission processes.
• Excellent communication skills for interaction with investigators, authorities and cross‑functional teams.
• Ability to manage multiple projects simultaneously and meet critical timelines.
• Experience in contract and budget negotiations within clinical research settings.

Required skills

What we offer

• Opportunity to work on innovative clinical studies at the forefront of medical research.
• Collaborative environment with global and local experts.
• Standard Monday‑Friday office schedule.